syngo. CT Single Source Dual Energy is designed to operate with CT images which have been acquired with Siemens Single Source scanners. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Single Source Dual Energy combines images acquired with low and high energy spectra to visualize this information. Depending on the region of interest, contrast agents may be used.

The functionality of the syngo.CT Single Source Dual Energy applications is as follows:

· Monoenergetic
Gout Evaluation
· Brain Hemorrhage
· Liver VNC
· Monoenergetic Plus
Bone Marrow
· Kidney Stones*)

*) Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid stones. For full identification of the kidney stone additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis under consideration of all available information. The accuracy of identification is decreased in obese patients.

Device Description

syngo.CT Single Source Dual Energy Software Package is a post processing application package consisting of several post processing application classes that can be used to improve visualization of various materials in the human body.

syngo.CT Single Source Dual Energy is a post processing software package designed to operate on the most recent version syngo.via client server platform, which supports preprocessing and loading of datasets by syngo.via depending on configurable rules.

After loading the two reconstructed image datasets acquired with two different X-ray spectra into syngo.CT Single Source Dual Energy, a registration is performed in case the image data sets are not acquired simultaneously, to compensate for potential motion effects. They are then displayed using linear blending with selectable mixing ratio and color scale. Multiplanar reformations (MPR) of the volume are shown in 3 image segments, which are initialized as sagittal, coronal and axial view.

After arriving at an initial diagnosis on the basis of the CT-images, the user can choose one of the following application classes:

Gout Evaluation
. Monoenergetic
Brain Haemorrhage
LiverVNC
Kidney Stones
. Monoenergetic Plus
Bone Marrow

These application classes are designed for specific clinical tasks, so that algorithms, additional tool buttons, the use of colored overlay images and image representation (for example MPR or maximum intensity projection) are optimized correspondingly.

AI/ML Overview

The Siemens syngo.CT Single Source Dual Energy software package (K133677) has a broad indication for use, stating it can aid in the visualization of the chemical composition of various materials in the human body by combining CT images acquired with low and high energy spectra. It lists several specific applications: Monoenergetic, Gout Evaluation, Brain Hemorrhage, Liver VNC, Monoenergetic Plus, Bone Marrow, and Kidney Stones.

For the Kidney Stones application, the indication for use specifies it is "designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid stones." It further states that "accuracy of identification is decreased in obese patients" and emphasizes that "Only a well-trained radiologist can make the final diagnosis under consideration of all available information."

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Kidney Stones Application: Ability to differentiate between uric acid and non-uric acid stones.	Kidney Stones Application: "The result of this study demonstrated that application Kidney Stones is able to differentiate between uric acid and non-uric acid stones."
Other Application Classes (Monoenergetic, Gout Evaluation, Brain Haemorrhage, Liver VNC, Monoenergetic Plus, Bone Marrow): Functionality of the application classes.	Other Application Classes: "Furthermore clinical data have been used to demonstrate the functionality of the other application classes."
Continued conformance with special controls for medical devices containing software.	Stated compliance with several IEC and ISO standards (IEC 60601-1-6, IEC 60601-1-4, IEC 62304, ISO 14971, DICOM). "Non clinical tests (integration and functional) and phantom testing were conducted..."
All software specifications met acceptance criteria.	"The testing results supports that all the software specifications have met the acceptance criteria."
Verification and validation of the device found acceptable to support claims of substantial equivalence.	"Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): For the Kidney Stones application, a "phantom study" was performed, but the specific number of phantoms or stone types tested is not provided. For the "other application classes," "clinical data" was used, but the sample size (number of patients/cases) and whether this data was retrospective or prospective is not specified.
Data Provenance: Not explicitly stated for either the phantom study or the clinical data. The document does not mention the country of origin. The clinical data appears to be retrospective as it's used to demonstrate functionality rather than being part of a controlled prospective trial described in detail.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. While the indication for use mentions that "Only a well-trained radiologist can make the final diagnosis," it does not detail the number or qualifications of experts involved in establishing ground truth for the performance studies.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in this document. The document focuses on the performance of the device itself rather than its impact on human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance studies described appear to be standalone (algorithm only). For the Kidney Stones application, a "phantom study was performed to test the ability of application kidney stones." For other applications, "clinical data have been used to demonstrate the functionality of the other application classes." These descriptions imply direct evaluation of the software's output rather than assessing human performance with or without the software.

7. The Type of Ground Truth Used

For the Kidney Stones application, the ground truth was likely based on the known composition of the phantom stones ("phantom study... differentiate between uric acid and non-uric acid stones").
For the "other application classes," the "clinical data" used to demonstrate functionality would have had an associated ground truth, but the specific type (e.g., pathology, expert consensus, outcomes data) is not specified.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. The descriptions focus on verification and validation testing, not the development or training of the algorithms. Given that this is a 510(k) for an updated software package, it's possible that the core algorithms were developed using proprietary datasets not disclosed here, or that the system relies on physical principles rather than extensive machine learning requiring a distinct "training set" in the modern sense.

9. How the Ground Truth for the Training Set Was Established

As the document does not mention a training set, it also does not provide information on how its ground truth was established.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a symbolic representation of a wing or feather extending from the head of the first profile.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 16, 2014

Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Technical Specialist 51 Valley Stream Parkway MALVERN PA 19355

Re: K133677

Trade/Device Name: syngo.CT Single Source Dual Energy Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 10, 2014 Received: September 17, 2014

Dear Ms. Mangum:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Smh

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K133677

Device Name syngo.CT Single Source Dual Energy

Indications for Use (Describe)

The functionality of the syngo.CT Single Source Dual Energy applications is as follows:

· Monoenergetic
Gout Evaluation
· Brain Hemorrhage
· Liver VNC
· Monoenergetic Plus
Bone Marrow
· Kidney Stones*)

Type of Use (Select one or both, as applicable)

|× Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. The word is displayed horizontally and is the main focus of the image.

510(k) Summary

FOR

synqo.CT Single Source Dual Energy Software Package

Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355

Date Prepared: September 8, 2014

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

1. General Information

Importer/Distributor:

Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355

Establishment Registration Number: 2240869

Manufacturing Site:

Siemens AG Medical Solutions Henkestraße 127 D-91052 Erlangen, Germany

Establishment Registration Number: 3002808157

2. Contact Person:

Mrs. Kimberly Mangum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway D02 Malvern, PA 19355-1406 Phone: (610) 448-1772 Fax: (610) 448-1778 Email: kimberly.mangum@siemens.com

3. Device Name and Classification

Product Name:	syngo.CT Single Source Dual Energy
Propriety Trade Name:	syngo.CT Single Source Dual Energy
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology

{5}------------------------------------------------

CFR Section:	21 CFR §892.1750
Device Class:	Class II
Product Code:	90JAK

Legally Marketed Predicate Devices SOMATOM DRI X-Ray Scanner CT System Trade Name: 510(k)#: K837107 Clearance Date: March 09, 1983 System, X-Ray, Tomography, Computed Classification Name: Classification Panel: Radiology Classification Regulation:21 CFR § 892.1750 Device Class: ll Product Code: JAK

Trade Name:	syngo® Dual Energy with extended functionality
510(k)#:	K083524
Clearance Date:	April 01, 2009
Classification Name:	System, X-Ray, Tomography, Computed
Classification Panel:	Radiology
Classification Regulation:	21 CFR § 892.1750
Device Class:	II
Product Code:	90 JAK

Trade Name:	syngo® Single Source Dual Energy
510(k)#:	K122909
Clearance Date:	December 27, 2012
Classification Name:	System, X-Ray, Tomography, Computed
Classification Panel:	Radiology
Classification Regulation:	21 CFR § 892.1750
Device Class:	II
Product Code:	90 JAK

4. Substantial Equivalence:

The subject device syngo.CT Single Source Dual Energy software package is substantially equivalent to following medical devices in commercial distribution:

Predicate Device Name	FDA Clearance Number	FDA Clearance Date
syngo® Dual Energy Software Package	K083524	April 1, 2009
syngo® Single Source Dual Energy Software Package	K122909	December 27, 2012
SOMATOM DRI X-Ray Scanner CT System	K837107	March 09, 1983

{6}------------------------------------------------

5. Device Description:

Dual energy offers functions for qualitative and quantitative evaluations. Dual energy CT can be used to improve the visualization of the chemical composition of various energy dependent materials in the human body when compared to single energy CT.

Depending on the organ of interest, the user can select and modify different application classes or parameters and algorithms. syngo.CT Single Source Dual Energy Software Package is a post processing application package consisting of several post processing application classes that can be used to improve visualization of various materials in the human body.

After arriving at an initial diagnosis on the basis of the CT-images, the user can choose one of the following application classes:

Gout Evaluation
. Monoenergetic
Brain Haemorrhage
LiverVNC
Kidney Stones
. Monoenergetic Plus
Bone Marrow

6. Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:

syngo.CT Single Source Dual Energy Software Package is a post processing application operating on the multi-user syngo.via client server platform. The subject syngo.CT Single Source Dual Energy provides similar evaluation,

{7}------------------------------------------------

reporting and visualization tools, and functionality as the predicate device syngo® Single Source Dual Energy. This includes image processing and visualization tools such as basic visualization of various energy dependent materials in the human body and VRT visualization. In addition to the previously cleared Monoenergetic and Gout Evaluation single source dual energy applications, syngo.CT Single Source Dual Energy also supports the following single source dual energy post processing application classes:

Brain Haemorrhage
· Liver VNC
· Monoenergetic Plus
Bone Marrow
Kidney Stones

syngo.CT Single Source Dual Energy does not have significant changes in technological characteristics when compared to the predicate devices. The Indication for Use, operating principle, and the scientific technology are similar; therefore, Siemens believes that syngo.CT Single Source Dual Energy Package is substantially equivalent to the predicate devices.

7. Nonclinical Testing:

syngo.CT Single Source Dual Energy Software Package is designed to fulfill the requirements of following standards:

IEC 60601-1-6 : 2007; Medical electrical equipment Part 1-6: General . requirements for basic safety and essential performance - Collateral Standard: Usability
IEC 60601-1-4:2000; Consol. Ed. 1.1, Medical electrical equipment Part . 1-4: General requirements for safety -- Collateral standard: Programmable electrical medical systems, edition 1.1
IEC 62304 Ed. 1.0, "Medical Device Software Software Lifecycle ● Processes"
ISO 14971:2007; Medical devices Application of risk management to ● medical devices
Digital Imaging and Communications in Medicine (DICOM) Set Standard: 2008 DICOM conformity is fully covered by syngo.via implementations.

This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non clinical tests (integration and functional) and phantom testing were conducted for syngo.CT Single Source Dual Energy during product development. The modifications described in the Premarket Notification were supported with verification/validation as well as phantom testing.

Performance studies and phantom studies were conducted to test the functionality of the syngo.CT Dual Energy post processing applications. A phantom study was performed to test the ability of application kidney stones.

{8}------------------------------------------------

The result of this study demonstrated that application Kidney Stones is able to differentiate between uric acid and non-uric acid stones. Furthermore clinical data have been used to demonstrate the functionality of the other application classes.

The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.

Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.

Summary of Additional Testing

In addition to successful completion of verification and validation testing, additional bench testing was performed to substantiate performance claims and demonstrate substantial equivalence to the predicate devices. Sample clinical images were also provided within the submission.

8. Indications for Use:

syngo.CT Single Source Dual Energy is designed to operate with CT images which have been acquired with Siemens Single Source scanners. The various materials of an anatomical reqion of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Single Source Dual Energy combines images acquired with low and high energy spectra to visualize this information. Depending on the region of interest, contrast agents may be used.

The functionality of the syngo.CT Single Source Dual Energy applications is as follows:

Monoenergetic
Gout Evaluation ●
Brain Hemorrhage ●
Liver VNC ●
Monoenergetic Plus ●
Bone Marrow
Kidney Stones®

*) Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid and non-uric acid stones. For full identification of the kidney stone

{9}------------------------------------------------

additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis under consideration of all available information. The accuracy of identification is decreased in obese patients.

9. General Safety and Effectiveness Concerns:

The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.

Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development. verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

10. Conclusion as to Substantial Equivalence

In summary, Siemens is of the opinion that the syngo.CT Single Source Dual Energy Software Package does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.